Cleared Traditional

HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950

K071510 · Focus Diagnostics, Inc. · Microbiology

Sep 2007

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K071510 is an FDA 510(k) clearance for the HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950, a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (Class II — Special Controls, product code MXJ), submitted by Focus Diagnostics, Inc. (Cypress, US). The FDA issued a Cleared decision on September 24, 2007, 112 days after receiving the submission on June 4, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K071510 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2007
Decision Date	September 24, 2007
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	MXJ — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3305